Diagnosing Drug Allergy: the T is the Key

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-21

Study Completion Date

2027-09-30

Brief Summary

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The goal of this clinical trial is to validate a newly developed test in the diagnosis of patients with amoxicillin allergy (i.e. T-cell activation test). The main questions the study aims to assess are the reliability and applicability of this test. Participants will be asked to visit the hospital 1, 3 or 5 times during which blood is collected and when applicable, allergy skin testing is performed.

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Detailed Description

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Drug allergy is a significant health issue with a serious medical and financial burden of mis- and overdiagnosis. Currently applied tests differ for immediate and nonimmediate drug allergy and have variable sensitivity and specificity. Therefore, correct diagnosis remains difficult and frequently requires potentially dangerous and time-consuming challenge tests. Drug-specific T-cells play a central role in initiation and maintenance of both immediate and nonimmediate drug allergy and can be studied in the lymphocyte transformation test (LTT). However, technical difficulties have hindered entrance of the LTT in mainstream use. The investigators' data indicates that flow-based intracellular trapping and staining of markers induced during activation (such as CD154 and cytokines) enables a rapid enumeration of rare drug-specific T-cells in the blood of patients with immediate and nonimmediate amoxicillin allergy. The ambition of this project is to validate a "one fits all" assay that meets the requirements of a safe, patient friendly, accessible, and performant test that could merits the status of a primary investigation in the diagnostic algorithms. Moreover, as the tests is cost effective, it could also become an attractive method for broader applications such as the delabelling of spurious allergies. This project will focus on allergy to amoxicillin.

Conditions

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Amoxicillin Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with a suspected amoxicillin allergy

Patients with a suspected amoxicillin allergy for which the diagnostic work-up was performed at the hospital for the possible diagnosis of amoxicillin allergy.

Group Type EXPERIMENTAL

T-cell activation test using intracellular markers

Intervention Type DEVICE

A blood sample will be taken which is needed for the T-cell activation test (TAT). The TAT will than be performed by trained laboratory personnel.

Interventions

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T-cell activation test using intracellular markers

A blood sample will be taken which is needed for the T-cell activation test (TAT). The TAT will than be performed by trained laboratory personnel.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Participants are eligible if they:

* Are ≥ 6 years
* Are capable of informed consent, or if appropriate, participants have an acceptable individual capable of giving consent on the participant's behalf (e.g. parent or guardian of a child under 18 years of age)
* Have a suspected history of amoxicillin allergy

Exclusion Criteria

* Patients who are lacking capacity or do not have an acceptable individual capable to provide informed consent
* Pregnant women
* Breastfeeding women

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes